CEN/TC 264 - |
Air quality |
Project
| Reference | EN 285:2015 |
|---|---|
| Title | Sterilization - Steam sterilizers - Large sterilizers |
| Work Item Number | 00102114 |
| Abstract/Scope | This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizers for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads. This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l. Large steam sterilizers can also be used during the commercial production of medical devices. This European Standard does not specify requirements for equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process biological waste or human tissues. This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer. NOTE 1 Attention is drawn to the standards for quality management systems e.g. EN ISO 13485. NOTE 2 Environmental aspects are addressed in Annex A. |
| Status |
Published
|
| Reference Document | |
| date of Availability (DAV) | 2015-12-23 |
| ICS | 11.080.10 - Sterilizing equipment |
| A-Deviation(s) | |
| Special National Condition(s) |
Legal
| Directive(s) | 93/42/EEC |
|---|---|
| Mandate(s) | M/023 |
| Citation in OJEU | 93/42/EEC (Expected) |
Implementation Dates
| date of Ratification (DOR) (1) | 2015-11-15 |
|---|---|
| date of Availability (DAV) (2) | 2015-12-23 |
| date of Announcement (DOA) (3) | 2016-03-31 |
| date of Publication (DOP) (4) | 2016-06-30 |
| date of Withdrawal (DOW) (5) | 2018-12-23 |
Relations
| Supersedes | EN 285:2006+A2:2009 |
|---|---|
| Normative reference (6) |
EN 1041:2008+A1:2013
EN 13445-1:2014 EN 13445-2:2014 EN 13445-3:2014 EN 13445-4:2014 EN 13445-5:2014 EN 13445-8:2014 EN 14222:2003 EN 22768-1:1993 EN 60204-1:2006 EN 60584-1:2013 EN 60751:2008 EN 60770-1:2011 EN 61010-1:2010 EN 61010-2-040:2005
EN 61326-1:2013
EN 764-7:2002 EN 867-5:2001 EN ISO 11140-3:2009 EN ISO 12100:2010 EN ISO 13408-2:2011
EN ISO 228-1:2003
EN ISO 3746:2010 |
| Sales Points |
|
(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved
(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat
(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level
(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement
(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn
(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.
In the case of undated standard, a link to the last dated version is provided.
In the case of series, a link to each standard identified in the series is provided.
We also invite you to check (via the website) whether corrigenda and/or amendments shall be read in conjunction with the main standard.